Ocrelizumab And Hyaluronidase

Contraindications

4 CONTRAINDICATIONS OCREVUS ZUNOVO is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ] A history of life-threatening administration reaction to ocrelizumab [see Warnings and Precautions (5.1) ] A history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO [see Warnings and Precautions (5.1) ] . Active hepatitis B virus infection ( 4 ) History of life-threatening administration reactions to ocrelizumab ( 4 ) History of hypersensitivity to ocrelizumab, hyaluronidase, or to any component of OCREVUS ZUNOVO ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary OCREVUS ZUNOVO is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS ZUNOVO or ocrelizumab-containing products in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to OCREVUS ZUNOVO or ocrelizumab-containing products have not been studied in clinical trials. The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2) ] . Following administration of ocrelizumab to pregnant monkeys at doses similar to or greater than those used clinically, increased perinatal mortality, depletion of B-cell populations, and renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data OCREVUS ZUNOVO for subcutaneous injection contains ocrelizumab and hyaluronidase [see Description (11) ]. Ocrelizumab: - Following intravenous administration of ocrelizumab to monkeys during organogenesis (loading doses of 15 or 75 mg/kg on gestation days 20, 21, and 22, followed by weekly doses of 20 or 100 mg/kg), depletion of B-lymphocytes in lymphoid tissue (spleen and lymph nodes) was observed in fetuses at both doses. - Intravenous administration of ocrelizumab (three daily loading doses of 15 or 75 mg/kg, followed by weekly doses of 20 or 100 mg/kg) to pregnant